Chronic MigrainePhase 1TMS-CHROMIGNCT01496950
Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine
A Phase 1 study testing 10Hz active rTMS in people with Chronic Migraine, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive treatment of chronic migraine, compared to placebo repetitive transcranial magnetic stimulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- 10Hz active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2008to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic migraine according to the criteria of the International Headache Society
- no change in prophylactic medication in the past 3 months
Who cannot join
- other neurological disorders
- bipolar disorder
- alcohol or drug dependence in the past 2 months
- suicidal ideation, psychotic symptoms
- contraindications to transcranial magnetic stimulation (cardiac pacemaker, implanted electronic devices, metal in the skull, skull fractures, history of seizures)
- use of antidepressants in the past 4 weeks
- pregnancy or lack of birth-control method in women of childbearing age
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, 05652901
About this study
Official title: Double-blind Randomized Clinical Trial to Evaluate Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Preventive Treatment of Chronic Migraine
The purpose of this study is to determine whether active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive treatment of chronic migraine, compared to placebo repetitive transcranial magnetic stimulation.
Read the detailed description
Patients with chronic migraine according to the criteria of the International Headache Society will be randomized to either active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex or placebo repetitive transcranial magnetic stimulation, in a total of 23 sessions of treatment (15 sessions in the first month and 8 sessions in the second month of treatment). Outcomes will be evaluated at baseline, after one, two months after treatment, and one month after end of treatment
- Conditions
- Chronic Migraine
- Being tested
- 10Hz active rTMS, Placebo
- Keywords
- migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10Hz active rTMSDevice
Also called Repetitive transcranial magnetic stimulation
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
PlaceboDevice
Also called Repetitive transcranial magnetic stimulation
10Hz placebo rTMS delivered to the vertex
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Active rTMS | Active comparator | 10Hz active rTMS delivered to the left dorsolateral prefrontal cortex Receives: Device: 10Hz active rTMS |
| Placebo | Placebo comparator | 10Hz placebo rTMS delivered to the vertex Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days with pain per month
Measured: After all treatment sessions (total, 23 sessions within 60 days)
Secondary outcomes (1)
adverse effects
Measured: After all treatment sessions (total, 23 sessions within 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Adriana Conforto, Hospital Israelita Albert Einstein
- Investigators
- Adriana Conforto, MD,PHD, Principal investigator, Instituto Israelita de Ensino e Pesquisa Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496950
- Sponsor's protocol ID
- IIEP394-07
- Acronym
- TMS-CHROMIG
- Status last verified
- Apr 2018
- First submitted
- 25 May 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Clinical Trial to Evaluate Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Preventive Treatment of Chronic Migraine
- ClinicalTrials.gov ID
- NCT01496950
- Acronym / sponsor ID
- TMS-CHROMIG / IIEP394-07
- Conditions
- Chronic Migraine
- Keywords
- migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive treatment of chronic migraine, compared to placebo repetitive transcranial magnetic stimulation.
Detailed description
Patients with chronic migraine according to the criteria of the International Headache Society will be randomized to either active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex or placebo repetitive transcranial magnetic stimulation, in a total of 23 sessions of treatment (15 sessions in the first month and 8 sessions in the second month of treatment). Outcomes will be evaluated at baseline, after one, two months after treatment, and one month after end of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Active rTMS | Active comparator | Device: 10Hz active rTMS10Hz active rTMS delivered to the left dorsolateral prefrontal cortex |
| Placebo | Placebo comparator | Device: Placebo10Hz placebo rTMS delivered to the vertex |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic migraine according to the criteria of the International Headache Society
- no change in prophylactic medication in the past 3 months
Key exclusion criteria (7 listed)
- other neurological disorders
- bipolar disorder
- alcohol or drug dependence in the past 2 months
- suicidal ideation, psychotic symptoms
- contraindications to transcranial magnetic stimulation (cardiac pacemaker, implanted electronic devices, metal in the skull, skull fractures, history of seizures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10Hz active rTMSAlso: Repetitive transcranial magnetic stimulation10Hz active rTMS delivered to the left dorsolateral prefrontal cortex | Device | Active Comparator: Active rTMS |
| PlaceboAlso: Repetitive transcranial magnetic stimulation10Hz placebo rTMS delivered to the vertex | Device | Placebo |
Primary outcome
number of days with pain per month
Time frame: After all treatment sessions (total, 23 sessions within 60 days)
1 secondary outcome
adverse effects
Time frame: After all treatment sessions (total, 23 sessions within 60 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Conforto, MD,PHD principal investigator
Instituto Israelita de Ensino e Pesquisa Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10Hz active rTMS in people with Chronic Migraine, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of days with pain per month (time frame: After all treatment sessions (total, 23 sessions within 60 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.